Solid TumorPhase 1NCT07893535
An Investigational Study of BON-106 in Adults With Advanced or Metastatic Solid Tumors
A Phase 1 study testing BON-106 in people with Solid Tumor and Advanced Solid Tumor, run by BeOne Medicines.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BON-106 in adults with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Advanced Solid Tumor, Metastatic Solid Tumor
- What is being tested?
- BON-106
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be ≥ 18 years of age and must sign the ICF and be capable of giving written informed consent
- Patients must have either experienced disease recurrence or progression following standard systemic therapy, been intolerant of or ineligible for standard therapy, have no standard treatment available or no satisfactory alternative treatment as determined by the investigator.
- Tumors harboring actionable genomic alterations, patients must have experienced disease recurrence or progression following ≥ 1 approved targeted therapy for advanced or metastatic disease, where applicable.
- For Phase 1b, patients with advanced or metastatic disease in select solid tumors must have received ≥ 1 but no more than 2 or 3 prior lines of systemic therapy for advanced or metastatic disease.
- Patients must provide agreement for collection of tumor tissue samples.
- Must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
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- Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Adequate organ function
- Must be willing to use effective birth control for the duration of the study
Who cannot join
- History of severe allergic reactions or hypersensitivity to other monoclonal antibodies (mAbs), bispecific antibodies (BsAbs), or trispecific antibodies (TsAbs), or the active ingredients and excipients of BON-106.
- Active leptomeningeal disease, primary brain tumors, or uncontrolled, untreated brain metastasis.
- Active autoimmune diseases that may relapse.
- Patients with immunodeficiency as assessed by the investigator to be not suitable for treatment with immune modulating anticancer agents, prior allogeneic stem cell transplantation, or organ transplantation.
- Patients with infection (including tuberculosis infection, or other) requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study drug(s).
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BON-106 Alone or in Combination With Other Anticancer Agents in Patients With Advanced or Metastatic Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BON-106 in adults with advanced or metastatic solid tumors.
Read the detailed description
A solid tumor is an abnormal lump or mass of tissue that forms when cells grow out of control. Solid tumors can develop in organs, bones, or soft tissues. An advanced or metastatic solid tumor is a cancer that has either grown into nearby tissues (advanced) or spread to distant parts of the body (metastatic).
BON-106 is an experimental immunotherapy that is designed to activate immune cells that can recognize and attack tumor cells.
The purpose of this study is to test the safety and tolerability of BON-106 and identify the recommended dose and dosing schedule that can be taken without having serious side effects in adults with advanced or metastatic solid tumors. It will also test to see how well BON-106 works in adults with selected types of solid tumors.
This study consists of 2 phases, one called dose escalation and one called dose expansion. During the dose escalation phase, the study doctors will test different doses of BON-106 to find the recommended dose that people can take without having serious side effects. During the dose expansion phase, the study doctors will test BON-106 in a larger number of people with specific tumor types using the dose(s) identified from the dose escalation phase of the study.
The study will enroll adults at multiple centers worldwide with advanced or metastatic solid tumors. The overall time to participate in this study is about 28 months. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests.
- Conditions
- Solid Tumor, Advanced Solid Tumor, Metastatic Solid Tumor
- Being tested
- BON-106
- Keywords
- BON-106, Immunotherapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BON-106Drug
Administered by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | Sequential cohorts of increasing dose levels of BON-106 will be evaluated. Receives: Drug: BON-106 |
| Phase 1b Dose Expansion | Experimental | Participants with selected advanced solid tumors will receive BON-106 at the selected dose(s). Receives: Drug: BON-106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation Phase: Number of Participants with Dose-limiting Toxicities (DLTs)
Measured: Up to approximately 1 month
Dose Escalation Phase: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Treatment-related Adverse Events (TRAEs), and Serious Adverse Events (SAEs)
Measured: From first dose of study drug until 30 days after last dose, up to approximately 24 months.
Dose Expansion Phase: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) with confirmation per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Measured: Up to approximately 24 months
Secondary outcomes (9)
Dose Escalation Phase: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) with confirmation per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Measured: Up to approximately 24 months
Duration of Response (DOR)
DOR is defined as the time from the first determination of an objective response until the first documentation of disease progression or death due to any cause, whichever occurs first.
Measured: Up to approximately 24 months
Disease Control Rate (DCR) at Week 12 and Week 24
DCR at 12 weeks and 24 weeks is defined as the percentage of participants who have CR, PR, or stable disease (SD) according to RECIST v1.1, and are alive and progression-free at the Week 12 and Week 24 assessment, respectively.
Measured: Week 12 and Week 24
Dose-Expansion Phase: Progression-free Survival (PFS)
PFS is defined as the time from the date of the first administration of study drug to the date of the first documentation of disease progression or death due to any cause, whichever occurs first.
Measured: Up to approximately 24 months
Serum Concentration of BON-106
Measured: Up to approximately 24 months
Maximum Observed Concentration of BON-106
Measured: Approximately 2 months
Area Under the Concentration-time Curve (AUC) of BON-106
Measured: Approximately 2 months
Elimination Half-life (t1/2) of BON-106
Measured: Approximately 2 months
Dose- Expansion Phase: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: From first dose of study drug until 30 days after last dose, up to approximately 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893535
- Sponsor's protocol ID
- BON-106-101
- Other IDs
- 2026-528171-40-00
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BON-106 Alone or in Combination With Other Anticancer Agents in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07893535
- Acronym / sponsor ID
- BON-106-101
- Conditions
- Solid Tumor, Advanced Solid Tumor, Metastatic Solid Tumor
- Keywords
- BON-106, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- BeOne MedicinesIndustry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BON-106 in adults with advanced or metastatic solid tumors.
Detailed description
A solid tumor is an abnormal lump or mass of tissue that forms when cells grow out of control. Solid tumors can develop in organs, bones, or soft tissues. An advanced or metastatic solid tumor is a cancer that has either grown into nearby tissues (advanced) or spread to distant parts of the body (metastatic).
BON-106 is an experimental immunotherapy that is designed to activate immune cells that can recognize and attack tumor cells.
The purpose of this study is to test the safety and tolerability of BON-106 and identify the recommended dose and dosing schedule that can be taken without having serious side effects in adults with advanced or metastatic solid tumors. It will also test to see how well BON-106 works in adults with selected types of solid tumors.
This study consists of 2 phases, one called dose escalation and one called dose expansion. During the dose escalation phase, the study doctors will test different doses of BON-106 to find the recommended dose that people can take without having serious side effects. During the dose expansion phase, the study doctors will test BON-106 in a larger number of people with specific tumor types using the dose(s) identified from the dose escalation phase of the study.
The study will enroll adults at multiple centers worldwide with advanced or metastatic solid tumors. The overall time to participate in this study is about 28 months. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | Drug: BON-106Sequential cohorts of increasing dose levels of BON-106 will be evaluated. |
| Phase 1b Dose Expansion | Experimental | Drug: BON-106Participants with selected advanced solid tumors will receive BON-106 at the selected dose(s). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must be ≥ 18 years of age and must sign the ICF and be capable of giving written informed consent
- Patients must have either experienced disease recurrence or progression following standard systemic therapy, been intolerant of or ineligible for standard therapy, have no standard treatment available or no satisfactory alternative treatment as determined by the investigator.
- Tumors harboring actionable genomic alterations, patients must have experienced disease recurrence or progression following ≥ 1 approved targeted therapy for advanced or metastatic disease, where applicable.
- For Phase 1b, patients with advanced or metastatic disease in select solid tumors must have received ≥ 1 but no more than 2 or 3 prior lines of systemic therapy for advanced or metastatic disease.
- Patients must provide agreement for collection of tumor tissue samples.
Key exclusion criteria (6 listed)
- History of severe allergic reactions or hypersensitivity to other monoclonal antibodies (mAbs), bispecific antibodies (BsAbs), or trispecific antibodies (TsAbs), or the active ingredients and excipients of BON-106.
- Active leptomeningeal disease, primary brain tumors, or uncontrolled, untreated brain metastasis.
- Active autoimmune diseases that may relapse.
- Patients with immunodeficiency as assessed by the investigator to be not suitable for treatment with immune modulating anticancer agents, prior allogeneic stem cell transplantation, or organ transplantation.
- Patients with infection (including tuberculosis infection, or other) requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study drug(s).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BON-106Administered by intravenous infusion | Drug | Phase 1a Dose Escalation, Phase 1b Dose Expansion |
Primary outcome
Dose Escalation Phase: Number of Participants with Dose-limiting Toxicities (DLTs)
Time frame: Up to approximately 1 month
Dose Escalation Phase: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Treatment-related Adverse Events (TRAEs), and Serious Adverse Events (SAEs)
Time frame: From first dose of study drug until 30 days after last dose, up to approximately 24 months.
Dose Expansion Phase: Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
ORR is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) with confirmation per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
9 secondary outcomes
Dose Escalation Phase: Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Duration of Response (DOR)
Time frame: Up to approximately 24 months
Disease Control Rate (DCR) at Week 12 and Week 24
Time frame: Week 12 and Week 24
Dose-Expansion Phase: Progression-free Survival (PFS)
Time frame: Up to approximately 24 months
Serum Concentration of BON-106
Time frame: Up to approximately 24 months
Maximum Observed Concentration of BON-106
Time frame: Approximately 2 months
Area Under the Concentration-time Curve (AUC) of BON-106
Time frame: Approximately 2 months
Elimination Half-life (t1/2) of BON-106
Time frame: Approximately 2 months
Dose- Expansion Phase: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From first dose of study drug until 30 days after last dose, up to approximately 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
BeOne Medicines
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BON-106 in people with Solid Tumor and Advanced Solid Tumor, run by BeOne Medicines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (1-877-828-5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation Phase: Number of Participants with Dose-limiting Toxicities (DLTs) (time frame: Up to approximately 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.